Comparing ultra-high-resolution CT and conventional angiography for coronary heart disease detection
Ultra-High Resolution CT vs. Conventional Angiography for Detecting Hemodynamically Significant Coronary Artery Disease - The Core-PRECISION MULTI-CENTER STUDY
This study is testing if a new type of CT scan can find serious heart disease better than the standard invasive method in people aged 45-85 who have a history of heart issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 45 Years to 85 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT04272060 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of ultra-high-resolution computed tomography (UHR-CT) compared to traditional invasive coronary angiography in detecting significant coronary heart disease (CHD). It will assess the diagnostic accuracy of UHR-CT in identifying hemodynamically significant CHD and compare it to conventional methods, focusing on factors such as radiation exposure and adverse events. Patients aged 45-85 with a history of CHD will be recruited, and the study will analyze the results based on both visual and quantitative assessments of coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates are patients aged 45-85 with a documented history of coronary heart disease and suspected obstructive coronary artery stenosis.
Not a fit: Patients with known allergies to iodinated contrast media or those with severe renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer, noninvasive alternative for diagnosing coronary heart disease, reducing the need for invasive procedures.
How similar studies have performed: Other studies have shown promising results with noninvasive imaging techniques, but this specific approach using UHR-CT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients aged 45-85 years with history of CHD will be asked to participate. History of CHD is defined as prior documentation of a coronary artery stenosis of 50% or greater by coronary angiography or by prior documentation of coronary artery revascularization by percutaneous coronary intervention (PCI). Women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study CTA. * Suspected obstructive coronary artery stenosis based on clinical history and/or noninvasive testing, prompting a clinical referral for invasive coronary angiography; and/or planned PCI within the next 60 days. * Ability to understand and willingness to sign the Informed Consent Form. Exclusion Criteria: * Known allergy to iodinated contrast media * History of multiple myeloma or previous organ transplantation * Elevated serum creatinine (\> 1.5mg/dl) or calculated creatinine clearance of \< 60 ml/min (using the Cockcroft-Gault formula * Atrial fibrillation or uncontrolled tachyarrhythmia, or advanced atrioventricular block (second or third-degree heart block) * Evidence of severe symptomatic heart failure (NYHA Class III or IV); * Known or suspected moderate or severe aortic stenosis * Previous coronary artery bypass or other cardiac surgery * Patients without a history of CHD who had no or only mild coronary calcification on chest CT imaging within the past 5 years or had most recent coronary calcium scan with a score \<400 * Suspected acute coronary syndrome * Presence of any other history or condition that the investigator feels would be problematic
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Armin A Zadeh, MD PhD — Johns Hopkins University
- Study coordinator: Aysa Ostovaneh, PharmD
- Email: aostova2@jh.edu
- Phone: 4104580198
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.